Information references the main component of the system.Other relevant device(s) are: product id: bi71000529, serial/lot #: unknown, ubd: , udi#: medtronic representative (rep) went to the site to test the equipment.Testing revealed that the buttons on the pendant were responding as intended.The customer was notified customer that when the system is near docking area, that they should raise the y drive and then redock it.System was operational.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with an.If information is provided in the future, a supplemental report will be issued.
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